Aerosolizable formulation

ABSTRACT

There is provided an aerosolizable formulation comprising: (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof; (ii) water; and (iii) menthol in an amount of at least about 3% by weight of the aerosolizable formulation, wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

PRIORITY CLAIM

The present application is a National Phase entry of PCT Application No.PCT/GB2020/052194, filed Sep. 11, 2020, which claims priority from GBApplication No. 1913232.3, filed Sep. 13, 2019, each of which is herebyfully incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to an aerosolizable formulation, theaerosolizable formulation, contained, delivery systems incorporatingsaid formulation, and electronic aerosol provision systems such aselectronic aerosol delivery systems (e.g. e-cigarettes) incorporatingsaid formulation.

BACKGROUND

Electronic aerosol delivery systems such as e-cigarettes generallycontain a reservoir of liquid which is to be turned into an aerosol,typically containing nicotine. When a user inhales on the device, aheater is activated to aerosolize or vaporize a small amount of liquid,which is inhaled by the user. The liquid for e-cigarettes may alsocontain a flavor component to provide a sensory experience to the user.In some circumstances, the liquid may contain a flavor component withoutnicotine.

Amongst the flavor components available to users is menthol. When usedin a nicotine-containing liquid, menthol can provide the user with aunique sensory and taste experience. However, the aerosolizableformulations containing menthol that are currently available to usersgenerally have relatively low levels of menthol contained within them.

SUMMARY

In accordance with some embodiments described herein, there is providedan aerosolizable formulation comprising:

-   -   i. one or more aerosol-forming agents selected from the group        consisting of mono-propylene glycol, di-propylene glycol,        1,3-propanediol, and mixtures thereof;    -   ii. water; and    -   iii. menthol in an amount of at least about 3% by weight of the        aerosolizable formulation,

wherein the weight ratio of the one or more aerosol forming agents towater is at least about 2:1.

In accordance with some embodiments described herein, there is alsoprovided a process for forming an aerosol, the process comprising:providing an aerosolizable formulation as defined herein, andaerosolizing the formulation.

In accordance with some embodiments described herein, there is alsoprovided a contained aerosolizable formulation comprising: a container,and an aerosolizable formulation as defined herein disposed within thecontainer.

In accordance with some embodiments described herein, there is alsoprovided a delivery system comprising the aerosolizable formulation asdefined herein.

In accordance with some embodiments described herein, there is alsoprovided an electronic aerosol provision system comprising (i) anaerosolizer for aerosolizing liquid for inhalation by a user of theelectronic aerosol provision system, (ii) a power supply comprising acell or battery for supplying power to the aerosolizer; and (iii) anaerosolizable formulation as defined herein.

In accordance with some embodiments described herein, there is alsoprovided the use of a base comprising (i) one or more aerosol-formingagents selected from the group consisting of mono-propylene glycol,di-propylene glycol, 1,3-propanediol, and mixtures thereof, and (ii)water in a weight ratio of at least about 2:1 for reducing thecrystallization of menthol from an aerosolizable formulation. In someembodiments, the aerosolizable formulation is the formulation definedherein.

DETAILED DESCRIPTION

As discussed herein, there is provided an aerosolizable formulationcomprising

-   -   i. one or more aerosol-forming agents selected from the group        consisting of mono-propylene glycol, di-propylene glycol,        1,3-propanediol, and mixtures thereof;    -   ii. water; and    -   iii. menthol in an amount of at least about 3% by weight of the        aerosolizable formulation,        wherein the weight ratio of the one or more aerosol forming        agents to water is at least about 2:1.

The present inventors have found that, by incorporating a one or moreaerosol-forming agents selected from the group consisting ofmono-propylene glycol, di-propylene glycol, 1,3-propanediol, andmixtures thereof and water in a weight ratio of at least about 2:1, anaerosolizable formulation may be provided which can incorporate at leastabout 3% by weight of menthol, whilst maintaining a good shelf-life.Advantageously, such formulations may be stable for prolonged periods oftime (such as for at least about 3 weeks) even when stored at relativelylow temperatures (e.g. room temperature or below). Typically,formulations for e-cigarettes (often referred to as “e-liquids”) may bestored at room temperature or below, and sometimes down to as low asabout 2° C., for example when transported via airplane or ship. However,at such low storage temperatures, it was previously found that mentholmay crystallize out of the formulation, which is not desirable as it maylead to an increased volume of the formulation and thus increasedleakage. This was particularly the case for any formulations containingat least about 3 wt % of menthol. It has now been surprisingly found bythe present inventors that the formulations described herein have areduction in the amount of menthol crystals forming during storage, evenwhen this level of at least about 3 wt % of menthol is included and evenwhen the formulation is stored at very low temperatures.

For ease of reference, these and further aspects are now discussed underappropriate section headings. As will be understood by the skilledperson, the teachings of each section are not limited to the section inquestion, but may be combined with other sections as appropriate.

Aerosol-Forming Agents

As discussed herein, the aerosolizable formulation includes one or moreaerosol-forming agents selected from the group consisting ofmono-propylene glycol, di-propylene glycol, 1,3-propanediol, andmixtures thereof. An aerosol is a suspension of particles of liquid,solid, or both, within a gas. As used herein, the phrase“aerosol-forming agent” indicates a compound, or mixture of compounds,which, when included in the formulation with the flavoring agent (i.e.menthol) and heated to a temperature between about 100° C. to about 250°C., forms a suspension of flavoring agent particles within its gaseousform. In other words, the aerosol-forming agent is involved in theformation of a suspension of the flavoring agent upon heating of theformulation.

In some embodiments, the one or more aerosol-forming agents is orcomprises mono-propylene glycol. In some embodiments, the one or moreaerosol-forming agents is mono-propylene glycol. In some embodiments,the one or more aerosol-forming agents is or comprises di-propyleneglycol. In some embodiments, the one or more aerosol-forming agents isor comprises 1,3-propanediol.

In some embodiments, the one or more aerosol-forming agents is presentin an amount of at least about 50% by weight of the aerosolizableformulation. In some embodiments, the one or more aerosol-forming agentsis present in an amount of at least about 60% by weight of theaerosolizable formulation.

As used herein, the term “the one or more aerosol-forming agents ispresent in an amount of . . . ” means “the one or more aerosol-formingagents selected from the group consisting of mono-propylene glycol,di-propylene glycol, 1,3-propanediol, and mixtures thereof is present inan amount of . . . ”. In other words, any reference to an amount of “theone or more aerosol-forming agents” refers to the total combined amountof mono-propylene glycol, di-propylene glycol and 1,3-propanediol.

In some embodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 55% toabout 95% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 95% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 90% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 85% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 80% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 75% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 60% toabout 70% by weight of the aerosolizable formulation. In someembodiments, the one or more aerosol forming agents (such asmono-propylene glycol) is present in an amount of from about 65% toabout 70% by weight of the aerosolizable formulation.

In some embodiments, the aerosolizable formulation comprisesmono-propylene glycol in an amount of from about 60% to about 95% byweight of the aerosolizable formulation. In some embodiments, theaerosolizable formulation comprises a combination of the one or moreaerosol-forming agents in an amount of from about 60% to about 95% byweight of the aerosolizable formulation, wherein the one or moreaerosol-forming agents consists of mono-propylene glycol and one or moreof di-propylene glycol and/or 1,3-propanediol.

Water

As discussed herein, the aerosolizable formulation comprises water. Thewater may be provided by any suitable liquid or aqueous source. In someembodiments, the water may be provided by distilled water, tap water ormixtures thereof. In some embodiments, the water is provided bydistilled water.

In some embodiments, the water is present in an amount of from about0.01% to about 20% by weight of the aerosolizable formulation. In someembodiments, the water is present in an amount of from about 0.1% toabout 20% by weight of the aerosolizable formulation. In someembodiments, the water is present in an amount of from about 1% to about20% by weight of the aerosolizable formulation. In some embodiments, thewater is present in an amount of from about 1% to about 20% by weight ofthe aerosolizable formulation. In some embodiments, the water is presentin an amount of from about 1% to about 17.5% by weight of theaerosolizable formulation.

In some embodiments, the water is present in an amount of from about2.5% to about 17.5% by weight of the aerosolizable formulation. In someembodiments, the water is present in an amount of from about 5% to about15% by weight of the aerosolizable formulation. In some embodiments, thewater is present in an amount of from about 5% to about 10% by weight ofthe aerosolizable formulation. In some embodiments, the water is presentin an amount of from about 10% to about 15% by weight of theaerosolizable formulation.

In some embodiments, the water is present in an amount of at least 1% byweight of the aerosolizable formulation. In some embodiments, the wateris present in an amount of at least 5% by weight of the formulation.

It has been found that the inclusion of water in the formulation (suchas in an amount of at least 1% by weight) leads to a formulation thathas reduced leakage. Without wishing to be bound by any theory, it isunderstood that, if no water is included in the formulation, then theone or more aerosol-forming agents (such as mono-propylene glycol) mayabsorb water from the surroundings. This may lead to an increase involume of the aerosolizable formulation. When provided in a container inan electronic aerosol provision system, any such increase in volume ofthe formulation may lead to leakage of the formulation, or at worstfailure of the device.

Base Comprising One or More Aerosol-Forming Agents and Water

As discussed herein, the aerosolizable formulation comprises (i) one ormore aerosol-forming agents selected from the group consisting ofmono-propylene glycol, di-propylene glycol, 1,3-propanediol, andmixtures thereof; and (ii) water, wherein the weight ratio of the one ormore aerosol-forming agents to water is at least about 2:1.

As used herein, the term “the weight ratio of the one or moreaerosol-forming agents to water” refers to the weight ratio between (i)the one or more aerosol-forming agents selected from the groupconsisting of mono-propylene glycol, di-propylene glycol,1,3-propanediol, and mixtures thereof, and (ii) water. In other words,the weight ratio is between the total combined amount of (i)mono-propylene glycol, di-propylene glycol and 1,3-propanediol, and (ii)water.

In some embodiments, the weight ratio of the one or more aerosol-formingagents (such as mono-propylene glycol) to water is at least about 2.5:1,such as at least about 3:1, such as at least about 3.5:1, such as atleast about 4:1, such as at least about 4.5:1, such as at least about5:1.

In some embodiments, the weight ratio of the one or more aerosol-formingagents (such as mono-propylene glycol) to water is greater than about2:1, such as greater than about 2.5:1, such as greater than about 3:1,such as greater than about 3.5:1, such as greater than about 4:1, suchas greater than about 4.5:1, such as greater than about 5:1.

In some embodiments, the weight ratio of the one or more aerosol-formingagents (such as mono-propylene glycol) to water is from about 2:1 toabout 60:1. In some embodiments, the weight ratio of the one or moreaerosol-forming agents (such as mono-propylene glycol) to water is fromabout 2:1 to about 50:1. In some embodiments, the weight ratio of theone or more aerosol-forming agents (such as mono-propylene glycol) towater is from about 2:1 to about 40:1. In some embodiments, the weightratio of the one or more aerosol-forming agents (such as mono-propyleneglycol) to water is from about 2:1 to about 30:1. In some embodiments,the weight ratio of the one or more aerosol-forming agents (such asmono-propylene glycol) to water is from about 2:1 to about 20:1. In someembodiments, the weight ratio of the one or more aerosol-forming agents(such as mono-propylene glycol) to water is from about 2:1 to about10:1.

In some embodiments, the weight ratio of the one or more aerosol-formingagents (such as mono-propylene glycol) to water is from about 2.5:1 toabout 10:1. In some embodiments, the weight ratio of the one or moreaerosol-forming agents (such as mono-propylene glycol) to water is fromabout 3:1 to about 8:1. In some embodiments, the weight ratio of the oneor more aerosol-forming agents (such as mono-propylene glycol) to wateris from about 3.5:1 to about 7:1. In some embodiments, the weight ratioof the one or more aerosol-forming agents (such as mono-propyleneglycol) to water is from about 4:1 to about 6:1.

In some embodiments, the weight ratio of the one or more aerosol-formingagents (such as mono-propylene glycol) to water is from about 4:1 toabout 60:1. In some embodiments, the weight ratio of the one or moreaerosol-forming agents (such as mono-propylene glycol) to water is fromabout 4:1 to about 20:1. In some embodiments, the weight ratio of theone or more aerosol-forming agents (such as mono-propylene glycol) towater is from about 4:1 to about 10:1.

In some embodiments, the one or more aerosol-forming agents ismono-propylene glycol. In some embodiments, the weight ratio ofmono-propylene glycol to water is at least about 2.5:1, such as at leastabout 3:1, such as at least about 3.5:1, such as at least about 4:1,such as at least about 4.5:1, such as at least about 5:1. In someembodiments, the weight ratio of mono-propylene glycol to water isgreater than about 2:1, such as greater than about 2.5:1, such asgreater than about 3:1, such as greater than about 3.5:1, such asgreater than about 4:1, such as greater than about 4.5:1, such asgreater than about 5:1.

It was surprisingly found by the present inventors that, when includedin a formulation comprising at least about 3 wt % of menthol, theinclusion of the one or more aerosol-forming agents selected from thelist as defined hereinabove and water in a weight ratio of at leastabout 2:1 provides an aerosolizable formulation having improvedstability. In particular, it was found that such formulations may havean improved shelf life when stored at temperatures of room temperatureor below (even down to about 2° C.) due to a reduction in the number ofmenthol crystals that are formed during storage.

Menthol

As discussed herein, the aerosolizable formulation of the presentinvention comprises menthol in an amount of at least 3% by weight of theaerosolizable formulation. As will be understood by the skilled person,menthol is typically regarded as being a flavoring agent.

In some embodiments, the menthol is food-grade. As will be understood bythe skilled person, the term “food-grade” refers to materials which arenon-toxic and safe for human consumption.

The menthol is present in an amount of at least about 3% by weight ofthe aerosolizable formulation. The amount of the menthol is defined withrespect to the total weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of at leastabout 3.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of at least about 4% byweight of the aerosolizable formulation. In some embodiments, thementhol is present in an amount of at least about 4.5% by weight of theaerosolizable formulation. In some embodiments, the menthol is presentin an amount of at least about 5% by weight of the aerosolizableformulation. In some embodiments, the menthol is present in an amount ofat least about 6% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of at least about 7% byweight of the aerosolizable formulation. In some embodiments, thementhol is present in an amount of at least about 8% by weight of theaerosolizable formulation. In some embodiments, the menthol is presentin an amount of at least about 9% by weight of the aerosolizableformulation. In some embodiments, the menthol is present in an amount ofat least about 10% by weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of greater thanabout 3.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of greater than about4% by weight of the aerosolizable formulation. In some embodiments, thementhol is present in an amount of greater than about 4.5% by weight ofthe aerosolizable formulation. In some embodiments, the menthol ispresent in an amount of greater than about 5% by weight of theaerosolizable formulation. In some embodiments, the menthol is presentin an amount of greater than about 6% by weight of the aerosolizableformulation. In some embodiments, the menthol is present in an amount ofgreater than about 7% by weight of the aerosolizable formulation. Insome embodiments, the menthol is present in an amount of greater thanabout 8% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of greater than about9% by weight of the aerosolizable formulation. In some embodiments, thementhol is present in an amount of greater than about 10% by weight ofthe aerosolizable formulation.

In some embodiments, the menthol is present in an amount of no greaterthan about 25% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of no greater thanabout 20% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of no greater thanabout 17.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of no greater thanabout 15% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of no greater thanabout 12.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of no greater thanabout 10% by weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of from about3% to about 20% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of from about 3.5% toabout 17.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of from about 4% toabout 15% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of from about 5% toabout 12.5% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of from about 5% toabout 10% by weight of the aerosolizable formulation. In someembodiments, the menthol is present in an amount of from about 5% toabout 7.5% by weight of the aerosolizable formulation.

In some embodiments, the weight ratio of the one or more aerosol formingagents (such as mono-propylene glycol) to menthol in the aerosolizableformulation is at least about 5:1, such as at least about 15:1, such asat least about 20:1. In some embodiments, the weight ratio of the one ormore aerosol forming agents (such as mono-propylene glycol) to mentholin the aerosolizable formulation is from about 5:1 to about 30:1, suchas from about 10:1 to about 25:1, such as from about 15:1 to about 20:1.

In some embodiments, the weight ratio of water to menthol in theaerosolizable formulation is at least about 1:1, such as at least about3:1, such as at least about 4:1. In some embodiments, the weight ratioof water to menthol in the aerosolizable formulation is from about 1:1to about 10:1, such as from about 2:1 to about 8:1, such as from about3:1 to about 7:1, such as from about 4:1 to about 7:1.

It was surprisingly found by the present inventors that the provision ofa formulation as defined herein enables the use of at least about 3 wt %of menthol in the formulation, whilst maintaining an acceptableshelf-life. In particular, it was found that the degree ofcrystallization of the menthol could be reduced even when stored at lowtemperatures. Such formulations were thus found to have an improvedshelf life when stored at low temperatures as compared with previousformulations having at least 3 wt % menthol. The improved shelf life ofthe present formulations is believed to be due to a reduction in thedegree of crystallization of the menthol.

Other Components

The aerosolizable formulation of the present invention may include oneor more further components. These components may be selected dependingon the nature of the formulation.

In some embodiments, the aerosolizable formulation further comprisesanother aerosol-forming agent in addition to the one or moreaerosol-forming agents described hereinabove. In some embodiments, theaerosolizable formulation further comprises at least one of glycerin(also called glycerin or glycerol), sugar alcohols (e.g. sorbitol,ethylene glycol, erythritol, threitol, arabitol, xylitol, ribitol,mannitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt,maltitol, lactitol), polyethylene glycol, diethylene glycol, triethyleneglycol, tetraethylene glycol, 1,3-butylene glycol, erythritol,meso-erythritol, ethyl vanillate, ethyl laurate, diethyl suberate,triethyl citrate, a diacetin mixture, benzyl benzoate, benzyl phenylacetate, tributyrin, lauryl acetate, lauric acid, myristic acid,propylene carbonate, or mixtures thereof. In some embodiments, theaerosolizable formulation further comprises at least one of glycerin(e.g., vegetable glycerin), sorbitol, xylitol, polyethylene glycol,diethylene glycol, triethylene glycol, tetraethylene glycol,1,3-butylene glycol, or mixtures thereof. For the avoidance of anydoubt, it is noted that the amount of any of these furtheraerosol-forming agents is not taken into account for determining theweight ratio of the one or more aerosol-forming agents to water; suchweight ratio constitutes the weight ratio of the total combined amountof mono-propylene glycol, di-propylene glycol and 1,3-propanediol towater.

In some embodiments, the aerosolizable formulation further comprisesglycerin (e.g. vegetable glycerin). In some embodiments, theaerosolizable formulation further comprises glycerin (e.g. vegetableglycerin) in an amount of from about 0.1% to about 40% by weight of theaerosolizable formulation, such as in an amount of from about 0.1% toabout 35% by weight of the aerosolizable formulation, such as in anamount of from about 1% to about 30% by weight of the aerosolizableformulation, such as in an amount of from about 5% to about 30% byweight of the aerosolizable formulation, such as in an amount of fromabout 10% to about 30% by weight of the aerosolizable formulation, suchas in an amount of from about 15% to about 30% by weight of theaerosolizable formulation, such as in an amount of from about 20% toabout 30% by weight of the aerosolizable formulation. In someembodiments, the aerosolizable formulation further comprises glycerin(e.g. vegetable glycerin) in an amount of from about 20% to about 25% byweight of the aerosolizable formulation. In some embodiments, theaerosolizable formulation further comprises glycerin (e.g. vegetableglycerin) in an amount of from about 25% to about 30% by weight of theaerosolizable formulation. The inclusion of glycerin in an aerosolizableformulation as defined herein may provide an improved aerosol. Forexample, the inclusion of glycerin in the formulation may lead to alarger volume of aerosol, which may be desirable for the user.

In some embodiments, the aerosolizable formulation further comprisespolyethylene glycol. In some embodiments, the aerosolizable formulationfurther comprises polyethylene glycol in an amount of from about 0.1% toabout 40% by weight of the aerosolizable formulation, such as in anamount of from about 0.1% to about 35% by weight of the aerosolizableformulation, such as in an amount of from about 1% to about 30% byweight of the aerosolizable formulation, such as in an amount of fromabout 5% to about 30% by weight of the aerosolizable formulation, suchas in an amount of from about 10% to about 30% by weight of theaerosolizable formulation, such as in an amount of from about 15% toabout 30% by weight of the aerosolizable formulation, such as in anamount of from about 20% to about 30% by weight of the aerosolizableformulation. In some embodiments, the aerosolizable formulation furthercomprises polyethylene glycol in an amount of from about 20% to about25% by weight of the aerosolizable formulation. In some embodiments, theaerosolizable formulation further comprises polyethylene glycol in anamount of from about 25% to about 30% by weight of the aerosolizableformulation.

In some embodiments, the aerosolizable formulation comprises acombination of mono-propylene glycol and glycerin, wherein the weightratio of mono-propylene glycol to water is at least about 2:1, such asat least about 4:1, such as greater than about 4:1. In some embodiments,the aerosolizable formulation comprises a combination of mono-propyleneglycol and polyethylene glycol, wherein the weight ratio ofmono-propylene glycol to water is at least about 2:1, such as at leastabout 4:1, such as greater than about 4:1.

In some embodiments, the aerosolizable formulation further comprises aflavoring agent in addition to menthol. The term “flavoring agent” maybe used interchangeably with “flavor” or “flavorant”, and these termsrefer to materials which, where local regulations permit, are added toan aerosolizable formulation to create a desired taste or aroma in aproduct for adult consumers. Reference here to “flavoring agent”,“flavor” or “flavorant” includes both singular and multi-componentflavors. It will also be understood by the skilled person that theaerosolizable formulation of the present invention can further includeone or more other flavoring agents, i.e. flavoring agents which are notmenthol.

Such flavoring agents can be selected from the group consisting oflicorice, hydrangea, Japanese white bark magnolia leaf, chamomile,fenugreek, clove, menthol, Japanese mint, aniseed, cinnamon, herb,wintergreen, cherry, berry, peach, apple, Drambuie, bourbon, scotch,whiskey, spearmint, peppermint, lavender, cardamom, celery, cascarilla,nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil,vanilla, lemon oil, orange oil, cassia, caraway, cognac, jasmine,ylang-ylang, sage, fennel, piment, ginger, anise, coriander, coffee,flavor enhancers, bitterness receptor site blockers, sensorial receptorsite activators or stimulators, sugars and/or sugar substitutes (e.g.sucralose, acesulfame potassium, aspartame, saccharine, cyclamates,lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and otheradditives such as charcoal, chlorophyll, minerals, botanicals, or breathfreshening agents. Any additional flavoring agent(s) may be imitation,synthetic or natural ingredients or blends thereof. They may be in anysuitable form, for example, oil, liquid, or powder.

In some embodiments, the aerosolizable formulation further comprises oneor more active agent(s). By “active agent” it is meant an agent whichhas a biological effect on a subject when the aerosol is inhaled. Theone or more active agents may be selected from nicotine, botanicals, andmixtures thereof. The one or more active agents may be of synthetic ornatural origin. The one or more active agent(s) could be an extract froma botanical, such as from a plant in the tobacco family. An exampleactive agent is nicotine.

Thus in some embodiments the present invention provides an aerosolizableformulation comprising:

-   -   (i) one or more aerosol-forming agents selected from the group        consisting of mono-propylene glycol, di-propylene glycol,        1,3-propanediol, and mixtures thereof,    -   (ii) water,    -   (iii) menthol in an amount of at least about 3% by weight of the        aerosolizable formulation, and    -   (iv) an active agent, wherein the weight ratio of the one or        more aerosol forming agents to water is at least about 2:1.

In some embodiments the active agent is nicotine. Thus in someembodiments the present invention provides an aerosolizable formulationcomprising:

-   -   (i) one or more aerosol-forming agents selected from the group        consisting of mono-propylene glycol, di-propylene glycol,        1,3-propanediol, and mixtures thereof,    -   (ii) water,    -   (iii) menthol in an amount of at least about 3% by weight of the        aerosolizable formulation, and    -   (iv) nicotine,        wherein the weight ratio of the one or more aerosol forming        agents to water is at least about 2:1.

Nicotine may be provided in any suitable amount depending on the desireddosage when inhaled by the user. In some embodiments, nicotine ispresent in an amount of no greater than about 6 wt % based on the totalweight of the aerosolizable formulation. In some embodiments, nicotineis present in an amount of from about 0.01 wt % to about 6 wt % based onthe total weight of the aerosolizable formulation. In some embodiments,nicotine is present in an amount of from about 0.1 wt % to about 6 wt %based on the total weight of the aerosolizable formulation. In someembodiments, nicotine is present in an amount of from about 0.5 wt % toabout 6 wt % based on the total weight of the aerosolizable formulation.In some embodiments, nicotine is present in an amount of from about 1 wt% to about 6 wt % based on the total weight of the aerosolizableformulation. In some embodiments, nicotine is present in an amount offrom about 1.8 wt % to about 6 wt % based on the total weight of theaerosolizable formulation.

In some embodiments, nicotine is present in an amount of no greater thanabout 5 wt % based on the total weight of the aerosolizable formulation,such as no greater than about 4 wt % based on the total weight of theaerosolizable formulation, such as no greater than about 3 wt % based onthe total weight of the aerosolizable formulation, such as no greaterthan about 2 wt % based on the total weight of the aerosolizableformulation, such as no greater than about 1.8 wt % based on the totalweight of the aerosolizable formulation.

In some embodiments, nicotine is present in an amount of from about 0.01wt % to about 5 wt % based on the total weight of the aerosolizableformulation. In some embodiments, nicotine is present in an amount offrom about 0.1 wt % to about 5 wt % based on the total weight of theaerosolizable formulation. In some embodiments, nicotine is present inan amount of from about 0.5 wt % to about 4 wt % based on the totalweight of the aerosolizable formulation. In some embodiments, nicotineis present in an amount of from about 0.8 wt % to about 3 wt % based onthe total weight of the aerosolizable formulation. In some embodiments,nicotine is present in an amount of from about 1 wt % to about 2.5 wt %based on the total weight of the aerosolizable formulation. In someembodiments, nicotine is present in an amount of from about 1.5 wt % toabout 2 wt % based on the total weight of the aerosolizable formulation.In some embodiments, nicotine is present in an amount of from about 1 wt% to about 1.8 wt % based on the total weight of the aerosolizableformulation.

In some embodiments, nicotine is present in an amount of from about 0.8wt % to about 1.8 wt % based on the total weight of the aerosolizableformulation.

In some embodiments, nicotine is present in an amount of less than about1.9 wt % based on the total weight of the aerosolizable formulation. Insome embodiments, nicotine is present in an amount of less than about1.8 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, the aerosolizable formulation may further containone or more acids. In some embodiments, the aerosolizable formulationmay contain one or more acids in addition to nicotine (as the activeagent). In some embodiments, the one or more acids may be one or moreorganic acids. In some embodiments, the one or more acids may be one ormore organic acids selected from the group consisting of benzoic acid,levulinic acid, malic acid, maleic acid, fumaric acid, citric acid,lactic acid, acetic acid, succinic acid, pyruvic acid, and mixturesthereof. When included in the formulation in combination with nicotine,the one or more acids may provide a formulation in which the nicotine isat least partially in protonated (such as monoprotonated and/ordiprotonated) form.

In some embodiments, the aerosolizable formulation further comprises atleast one functional material. The functional material may comprise oneor more of carriers, pH regulators, stabilizers, and/or antioxidants.

In some embodiments, the aerosolizable formulation is in the form of aliquid.

In some embodiments, the aerosolizable formulation is in the form of agel. In some embodiments, the aerosolizable formulation is not in theform of a gel.

Process

As discussed herein, there is provided a process for forming an aerosol,the process comprising (i) providing aerosolizable formulation asdefined herein, and (ii) aerosolizing the formulation.

In some embodiments, the formulation may be aerosolized by heating. Insome embodiments, the formulation may be aerosolized by mechanical means(e.g. via vibration of the aerosolizable formulation).

Further Aspects

The aerosolizable formulation may be contained or delivered by anymeans. In some embodiments, there is provided a contained aerosolizableformulation comprising (a) a container; and (b) an aerosolizableformulation as defined herein disposed within the container.

The container may be any suitable container, for example to allow forthe storage or delivery of the aerosolizable formulation. In someembodiments, the container is configured for engagement with anelectronic aerosol provision system. The container may be a bottle. Thecontainer may be configured to be or become in fluid communication withan electronic aerosol provision system so that the aerosolizableformulation may be delivered to the electronic aerosol provision system.As described above, the container may be used in an electronic aerosolprovision system, such as an e-cigarette. Throughout the followingdescription the term “e-cigarette” is used; however, this term may beused interchangeably with electronic aerosol provision system.

In some embodiments, the container is a cartridge configured to be orbecome in fluid communication with an electronic aerosol provisionsystem. The cartridge may be detachably connected to the electronicaerosol provision system or may be formed as an integral unit in thesystem.

As discussed herein, the container may typically be provided for thedelivery of the aerosolizable formulation to or within an e-cigarette.The aerosolizable formulation may be held within an e-cigarette or maybe sold as a separate container for subsequent use with or in ane-cigarette. As understood by one skilled in the art, e-cigarettes maycontain a unit known as a detachable cartomizer which typicallycomprises a reservoir of aerosolizable formulation, a wick material anda device for aerosolizing the aerosolizable formulation. In someembodiments, the container is a cartomizer or is part of a cartomizer.E-cigarettes may contain a cartomizer and a body portion. The bodyportion may include a power source (e.g. a rechargeable cell or battery)to provide power for the e-cigarette. In use, when the device foraerosolizing the formulation receives power from the battery, the deviceaerosolizes the aerosolizable formulation to generate an aerosol, andthis is then inhaled by a user through a mouthpiece which may beattached to the cartomizer either detachably or fixedly.

In some embodiments, the container is a cartomizer comprising areservoir of aerosolizable formulation, a wick material and a device(such as a heater) for aerosolizing the aerosolizable formulation. Insome embodiments, the cartomizer is part of a single-piece device and isnot detachable from a body portion as described above. In someembodiments, the cartomizer is configured to detachably connect to thebody portion (i.e. the cartomizer is a detachable cartomizer). Thecartomizer may be detached from the body portion and disposed of whenthe aerosolizable formulation is exhausted (and replaced with anothercartomizer if so desired). Such configurations are generally referred toas “closed electronic aerosol provision systems”.

Therefore, in some embodiments, the container is a closed systemcartridge or cartomizer for use in an electronic aerosol provisionsystem.

In some embodiments, the container is not a cartomizer or part of acartomizer and is a re-fillable container, such as a tank, which may beused to deliver aerosolizable formulation to or within an e-cigarette.As will be understood by the skilled person, such system may be referredto as an “open electronic aerosol provision system”.

In some embodiments, the container is part of an e-cigarette.

In accordance with some further embodiments described herein, there isprovided a delivery system comprising the aerosolizable formulation asdefined herein. As used herein, the term “delivery system” is intendedto encompass systems that deliver a substance to a user, and includes:

combustible aerosol provision systems, such as cigarettes, cigarillos,cigars, tobacco for pipes or for roll-your-own or make-your-owncigarettes (whether based on tobacco, tobacco derivatives, expandedtobacco, reconstituted tobacco, tobacco substitutes or other smokablematerial);

non-combustible aerosol provision systems that release compounds from anaerosolizable material without combusting the aerosolizable material,such as electronic cigarettes, tobacco heating products, and hybridsystems to generate aerosol using a combination of aerosolizablematerials; and

articles comprising aerosolizable material and configured to be usedwithin one of these non-combustible aerosol provision systems.

According to the present disclosure, a “combustible” aerosol provisionsystem is one where a constituent aerosolizable material of the aerosolprovision system (or component thereof) is combusted or burned duringuse in order to facilitate delivery to a user.

According to the present disclosure, a “non-combustible” aerosolprovision system is one where a constituent aerosolizable material ofthe aerosol provision system (or component thereof) is not combusted orburned in order to facilitate delivery to a user.

In some embodiments, the delivery system is a combustible aerosolprovision system, selected from the group consisting of a cigarette, acigarillo and a cigar.

In some embodiments, the disclosure relates to a component for use in acombustible aerosol provision system, such as a filter, a filter rod, afilter segment, a tobacco rod, a spill, an additive release componentsuch as a capsule, a thread, or a bead, or a paper such as a plug wrap,a tipping paper or a cigarette paper.

In some embodiments, the delivery system is a non-combustible aerosolprovision system, such as a powered or electronic non-combustibleaerosol provision system.

In some embodiments, the non-combustible aerosol provision system is anelectronic cigarette, also known as a vaping device or electronicnicotine delivery system (END), although it is noted that the presenceof nicotine in the aerosolizable formulation is not a requirement.

In some embodiments, the non-combustible aerosol provision system is atobacco heating system, also known as a heat-not-burn system.

In some embodiments, the non-combustible aerosol provision system is ahybrid system to generate aerosol using a combination of aerosolizablematerials, one or a plurality of which may be heated. Each of theaerosolizable materials may be, for example, in the form of a solid,liquid or gel and may or may not contain nicotine. In some embodiments,the hybrid system comprises a liquid or gel aerosolizable material and asolid aerosolizable material. The solid aerosolizable material maycomprise, for example, tobacco or a non-tobacco product. The liquid orgel aerosolizable material may be an aerosolizable formulation asdescribed herein.

Typically, the non-combustible aerosol provision system may comprise anon-combustible aerosol provision device and an article for use with thenon-combustible aerosol provision system. However, it is envisaged thatarticles which themselves comprise a means for powering an aerosolgenerating component may themselves form the non-combustible aerosolprovision system.

In some embodiments, the non-combustible aerosol provision device maycomprise a power source and a controller. The power source may be anelectric power source or an exothermic power source. In someembodiments, the exothermic power source comprises a carbon substratewhich may be energized so as to distribute power in the form of heat toan aerosolizable material or heat transfer material in proximity to theexothermic power source. In some embodiments, the power source, such asan exothermic power source, is provided in the article so as to form thenon-combustible aerosol provision device.

In some embodiments, the article for use with the non-combustibleaerosol provision device may comprise an aerosolizable material, anaerosol generating component, an aerosol generating area, a mouthpiece,and/or an area for receiving aerosolizable material. The aerosolizablematerial may be an aerosolizable formulation as described herein.

In some embodiments, the aerosol generating component is a heatercapable of interacting with the aerosolizable material so as to releaseone or more volatiles from the aerosolizable material to form anaerosol. In some embodiments, the aerosol generating component iscapable of generating an aerosol from the aerosolizable material withoutheating. For example, the aerosol generating component may be capable ofgenerating an aerosol from the aerosolizable material without applyingheat thereto, for example via one or more of vibrational, mechanical,pressurization or electrostatic means.

In some embodiments, the aerosolizable material is an aerosolizableformulation as defined herein, and may optionally comprise an activematerial. The active material may comprise nicotine (optionallycontained in tobacco or a tobacco derivative) or one or more othernon-olfactory physiologically active materials. A non-olfactoryphysiologically active material is a material which is included in theaerosolizable material in order to achieve a physiological responseother than olfactory perception.

In some embodiments, the article for use with the non-combustibleaerosol provision device may comprise aerosolizable material or an areafor receiving aerosolizable material. In some embodiments, the articlefor use with the non-combustible aerosol provision device may comprise amouthpiece. The area for receiving aerosolizable material may be astorage area for storing aerosolizable material. For example, thestorage area may be a reservoir. In some embodiments, the area forreceiving aerosolizable material may be separate from, or combined with,an aerosol generating area.

In accordance with some further embodiments described herein, there isprovided an electronic aerosol provision system comprising: (a) anaerosolizer for aerosolizing formulation for inhalation by a user of theelectronic aerosol provision system; (b) a power supply comprising acell or battery for supplying power to the aerosolizer; and (c) anaerosolizable formulation as defined herein. In some embodiments, theelectronic aerosol provision system is an electronic cigarette.

In some embodiments, the electronic aerosol provision system is ane-cigarette as defined hereinabove. In some embodiments, the electronicaerosol provision system is a closed system e-cigarette. As such, theelectronic aerosol provision system may include a body portion and acartomizer, wherein the cartomizer is detachably connected to the bodyportion. The body portion may include a power source (e.g. arechargeable cell or battery) to provide power for the e-cigarette. Thecartomizer may comprise a reservoir of aerosolizable formulation, a wickmaterial and an aerosolizer for aerosolizing the aerosolizableformulation. The aerosolizer for aerosolizing the aerosolizableformulation may be a heater. Alternatively or in addition, theaerosolizer for aerosolizing the aerosolizable formulation may be avibrating mesh. In use, when the device for aerosolizing the formulationreceives power from the battery, the aerosolizer aerosolizes theformulation to generate the aerosol, and this is then inhaled by a userthrough a mouthpiece which may be attached to the cartomizer eitherdetachably or fixedly.

In some embodiments, the electronic aerosol provision system may be anopen system e-cigarette which comprises a re-fillable container thathouses the aerosolizable formulation.

In addition to the aerosolizable formulation and to systems such ascontainers and electronic aerosol provision systems containing the same,there is provided the use of a base comprising (i) one or moreaerosol-forming agents selected from the group consisting ofmono-propylene glycol, di-propylene glycol, 1,3-propanediol, andmixtures thereof, and (ii) water in a weight ratio of at least about 2:1for reducing the crystallization of menthol from an aerosolizableformulation. In some embodiments, the stability of the aerosolizableformulation is improved by use of said base. In some embodiments, theaerosolizable formulation is the formulation as defined herein.

Examples

The following non-limiting examples serve to illustrate the surprisingbenefits of the present aerosolizable formulation.

The following formulations were prepared:

Comparative Formula (wt %) Example 1 Example 2 Example 3 Example 4Example 5 Example 1 Mono- 58.2 58.2 58.2 63.05 65 29.1 propylene glycol(PG) Water 14.55 13.58 12.61 14.55 12.5 19.4 Glycerin 24.25 25.22 26.1919.4 18.5 48.5 Menthol 3 3 3 3 4 3 Weight Ratio 4:1 4.29:1 4.62:1 4.33:15.2:1 1.5:1 of PG:Water

Each of Examples 1 to 5 were stored at a temperature of 2° C. for 24hours. Slight menthol crystal formation was observed in Example 1 after24 hours of being stored at this low storage temperature; no crystalswere visible in any of Examples 2 to 5 even when stored at this lowtemperature.

In contrast, Comparative Example 1 was stored at a higher temperature of15° C. Even at this high temperature, a significant number of mentholcrystals were observed after 24 hours.

Example 5 was also stored at 2° C. for a period of 6 weeks, andobservations were recorded after 24 hours, 1 week, 3 weeks and 6 weeks.It was found that, even after 6 weeks of storage at this lowtemperature, no signs of crystal formation were observed in theformulation.

It was thus found that a formulation comprising PG and water in a weightratio of at least about 2:1 provided a reduction in the amount ofcrystallization of menthol, even at temperatures as low as 2° C.

The various embodiments described herein are presented only to assist inunderstanding and teaching the claimed features. These embodiments areprovided as a representative sample of embodiments only, and are notexhaustive and/or exclusive. It is to be understood that advantages,embodiments, examples, functions, features, structures, and/or otheraspects described herein are not to be considered limitations on thescope of the invention as defined by the claims or limitations onequivalents to the claims, and that other embodiments may be utilizedand modifications may be made without departing from the scope of theclaimed invention. Various embodiments of the invention may suitablycomprise, consist of, or consist essentially of, appropriatecombinations of the disclosed elements, components, features, parts,steps, means, etc., other than those specifically described herein. Inaddition, this disclosure may include other inventions not presentlyclaimed, but which may be claimed in future.

1-16. (canceled)
 17. An aerosolizable formulation comprising: i. one ormore aerosol-forming agents selected from the group consisting ofmono-propylene glycol, di-propylene glycol, 1,3-propanediol, andmixtures thereof; ii. water; and iii. menthol in an amount of at leastabout 3% by weight of the aerosolizable formulation, wherein the weightratio of the one or more aerosol forming agents to water is at leastabout 2:1.
 18. The aerosolizable formulation of claim 17, wherein theformulation is a liquid.
 19. The aerosolizable formulation of claim 17,wherein the weight ratio of the one or more aerosol-forming agents towater is greater than about 3:1.
 20. The aerosolizable formulation ofclaim 17, wherein the one or more aerosol-forming agents ismono-propylene glycol.
 21. The aerosolizable formulation of claim 17,wherein the one or more aerosol-forming agents is present in an amountof from about 60% to about 95% by weight of the aerosolizableformulation.
 22. The aerosolizable formulation of claim 17, wherein thewater is present in an amount of from about 1% to about 20% by weight ofthe aerosolizable formulation.
 23. The aerosolizable formulation ofclaim 17, wherein the menthol is present in an amount of from about 3.5%to about 10% by weight of the aerosolizable formulation.
 24. Theaerosolizable formulation of claim 17, wherein the aerosolizableformulation further comprises an additional aerosol-forming agent,wherein the additional aerosol-forming agent is selected from the groupconsisting of glycerin, sugar alcohols, polyethylene glycol, diethyleneglycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol,erythritol, meso-erythritol, ethyl vanillate, ethyl laurate, diethylsuberate, triethyl citrate, a diacetin mixture, benzyl benzoate, benzylphenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid,propylene carbonate, or mixtures thereof.
 25. The aerosolizableformulation of claim 24, wherein the additional aerosol-forming agentcomprises glycerin.
 26. The aerosolizable formulation of claim 25,wherein the glycerin is present in an amount of from about 0.1% to about35% by weight of the aerosolizable formulation.
 27. The aerosolizableformulation of claim 17, wherein the formulation further comprises oneor more active agents.
 28. The aerosolizable formulation of claim 27,wherein the active agent is nicotine.
 29. The aerosolizable formulationof claim 28, wherein the nicotine is present in an amount of from about0.1% to about 6% by weight of the aerosolizable formulation
 30. Acontained aerosolizable formulation comprising a container and anaerosolizable formulation disposed within the container, theaerosolizable formulation comprising: i. one or more aerosol-formingagents selected from the group consisting of mono-propylene glycol,di-propylene glycol, 1,3-propanediol, and mixtures thereof; ii. water;and iii. menthol in an amount of at least about 3% by weight of theaerosolizable formulation, wherein the weight ratio of the one or moreaerosol forming agents to water is at least about 2:1.
 31. The containedaerosolizable formulation of claim 30, wherein the container is acartomizer adapted for use in connection with a closed electronicaerosol provision system.
 32. An electronic aerosol provision systemcomprising: an aerosolizer for turning a liquid into an aerosol forinhalation by a user of the electronic aerosol provision system; a powersupply comprising a cell or battery for supplying power to theaerosolizer; and an aerosolizable formulation; the aerosolizableformulation comprising: i. one or more aerosol-forming agents selectedfrom the group consisting of mono-propylene glycol, di-propylene glycol,1,3-propanediol, and mixtures thereof; ii. water; and iii. menthol in anamount of at least about 3% by weight of the aerosolizable formulation,wherein the weight ratio of the one or more aerosol forming agents towater is at least about 2:1.
 33. The electronic aerosol provision systemof claim 32, wherein the aerosolizable formulation is disposed within acontainer.
 34. The electronic aerosol provision system of claim 33,wherein the container is a cartomizer.
 35. The electronic aerosolprovision system of claim 34, wherein the electronic aerosol provisionsystem is a closed electronic aerosol provision system.
 36. Theelectronic aerosol provision system of claim 34, wherein the electronicaerosol provision system is an open electronic aerosol provision system.